"A validation quality plan must define, detail and mandate means and methods by which an approved change control concept can be progressed through the regulatory qualification process and into cGMP compliant production"
The Validation Quality Plan (VQP) is probably the most important of
all documents in a validation project. It is an essential document in giving
assurance that the validation task can be successfully executed in an effective, timely
and cost effective manner
. Simply because
this is the stage in the operation where all aspects of the validation are
highlighted, debated, allotted and budgeted for. Once the full scope of the
validation task is unearthed; then and then alone, can all these facets be
catered for and sensible time lines and responsibilities deliberated. To this end there may be several VA in
any major validation project. Each VP will cover
identical or similar equipment where the validation responsibilities and scopes
are identical or similar and can be adequately defined in one validation quality plan.
The top level of the User
Requirements Specifications (URS) must be in place to enable
the author(s) of the VP to start assessing; not only the basic user level
requirements but the attendant needs that the user level requirements make
requisite, such as; staff levels, user training, maintenance training, utility
and facility loadings. Along with
these requirements will come a multitude of other minor and major issues that
only ever become obvious after such extended and invasive studies are
completed. Only when these
requirements are fully reviewed and documented, can they be accurately
quantified. However once they are
defined, then the VP can start to allocate and document individual staff
responsibilities and individual and collective achievable time lines. Now the stage has arrived where a defined,
detailed and workable validation quality plan can be documented, reviewed, and subject
to reviewed comments being incorporated; issued by management as the official Validation
Quality plan of action.
The VP is the document that the company must use to authorize actual validation
methodologies, scopes and associated individual responsibilities (by job
title). It therefore has to work hand in hand with the
Risk assessment(VRA). The VA must list all the equipment that
it applies to and the VRA must be executed against each of the items in this
list. On completion of each
execution the appropriate scope of validation will be indicated by the VRA. This scope must be entered into the
appropriate section of the VP, before it becomes an approved and locked
controlled document. The VP will
therefore list the scope of validation applicable to each listed item along with
any individual specific methodologies that should be used.
The Validation Master Plan (VMP) is the single most important document because it describes the basic concept for your overall site validation program. This interactive detailed document is a delight and simple to use. The generic template and attached SOP lead you through the whole process quickly and seamlessly. This thirty page document is suitable for all types of pharmaceutical /biotechnical / medical device / API, manufacturer and or processer. The VMP addresses process validation, facility validation, utility validation, equipment qualification and cleaning validation. The objective is to define responsibilities, outline your methods involved in the qualification and validation of your facility, define the areas and systems to be qualified and validated and to provide a program for achieving and maintaining a validated status.
Search Our Store
To find a specific document enter full details in Search Box Below. The more defined the search is the more precise the search findings will be.
Select Preferred Language
When assistance is required; please contact us on TOLL-FREE 877-462-4048
If out of office hours; please leave a voice message.
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
SOP for Spreadsheet Creation. -- $125.00
The SOP for Computer Equipment Validation
continues to be an extremely popular document. This document leads you through
the validation process, from the URS to the final P2Q. The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
SOP Equipment Validation.
Purchase your copy now at Special Price of $22.00.
Validation Risk Assessment (Issue11.) -- $125.00
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.